Dec 22, 2017

Erelzi Products & Patients Weighing 63kg or Less

It was recently announced that Erelzi is now funded under the the Ontario Drug Benefit Program (ODBP) as a LU benefit for the following indications: RA, AS and pJIA. It was noted in conversations with the Ministry this week, however, that Erelzi products are not suitable for patients who weigh 63 kg or under. The Ministry responded immediately with a solution. Please review the letter below:

(Received from the MOHLTC December 21, 2017): 
Thank you for making us aware of the challenges of administering weight-based etanercept with the Erelzi products which include the 25mg/0.5mL and 50mg/mL prefilled syringes and the 50mg prefilled SensoReady pen during our meeting yesterday. 
 
We have been able to confirm with Sandoz, the manufacturer of Erelzi, that the syringe and pen formats of Erelzi do not have graduated markings to enable accurate measurement and administration of partial doses from the syringe and/or pen.  It is acknowledged that this will make it difficult to use Erelzi for the pJIA population weighing less than 63kg where weight-based dosing of 0.8mg/kg is common. Additionally, the current product monograph for Erelzi confirms the recommendation but it remains unusual that the product format is not manufactured in a way that considers the dosing needs for one of its marketed indications. 
 
As such, initial requests for Enbrel meeting funding criteria for pJIA will still be authorized through EAP or TFA(Rheumatology) mechanism for the treatment of pJIA to accommodate weight-based dosing for patients who are 63 kg or  under.  Initial requests for etanercept to treat pJIA for those 63kg or more  will be required to consider Erelzi as a limited use benefit.  Brenzys and Erelzi remain limited use options for initial requests for patients who are using the biologics to treat Rheumatoid arthritis and ankylosing spondylitis.
 
We have taken the following action:
We have notified the Ontario Rheumatology Association of the ongoing funding for initial requests for Enbrel for pJIA to accommodate weight-based dosing. Erelzi will continue to be the only option for initial requests for pJIA for those patients 63kg or more. This will include prescriptions written under the TFA(Rheumatology) mechanism.
We have informed EAP assessors to take note of this change when reviewing requests.
We will be working to send out an update and amendment to the EO notice.
We have notified Sandoz of this issue and they mentioned that they have passed this issue to their global team.
 
Thanks again for contacting us about this important observation before implementing the new Erelzi criteria


MOHLTC